MalariaEasyScanGoNCT03512678
Evaluation of a Digital Microscope for Malaria
An observational study of Malaria, run by University of Oxford at 1 site in Thailand.
Trial summary
Light microscopy, which is based on century-old technology, remains a key indicator in drug efficacy testing performed in the context of clinical trials for monitoring existing antimalarial drugs or in the context of regulatory clinical trials for registration of new drugs. Read more about this study
- Who is it for?
- Ages 6 months to 75 years
- Conditions the study is for
- Malaria
- How many people
- 2,250 participants
- Where
- 1 siteThailand
- Study dates
- 25 Jun 2018to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 75 years
- All sexes
- Child, Adult, Older adult
Study population: The multi-centric evaluation is currently planned for implementation at relatively few sites/countries and the primary criteria for the selection of sites will be based on operational feasibility of the project, i.e., availability of resources to perform the study procedures, adequate expected numbers of malaria positive cases, etc. Potential sites in Senegal, Kenya, Tanzania, Uganda, Congo, South Africa, Burkina Faso, Brazil, Thailand, Indonesia, Bangladesh, Myanmar and Cambodia are being considered for the study. A minimum of 80 malaria cases confirmed by expert microscopy and a minimum of 80 malaria-negative cases per study site.
Who may be able to join
- Male or female subjects, age ≥ 6 months to 75 years
- Febrile at presentation or history of fever in the past 48 hours (≥ 37.5 ºC) and no other obvious diagnosis or cause for fever, warranting malaria investigation under routine clinical practice.
- Individual informed assent/consent obtained
Who cannot join
- Signs of severe malaria as defined by WHO
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Centric Evaluation of a Device for Automated Malaria Microscopy (EasyScan Go)
Light microscopy, which is based on century-old technology, remains a key indicator in drug efficacy testing performed in the context of clinical trials for monitoring existing antimalarial drugs or in the context of regulatory clinical trials for registration of new drugs. It is one of the main diagnostic methods for malaria diagnosis in general, as in an ideal setting it can provide low-cost accurate diagnosis, determine the density of parasites in the blood, and accurately differentiate between different malaria parasite species, characteristics vital to the implementation of global plans for drug efficacy monitoring. Malaria rapid tests (RDTs), while useful for rapid diagnosis and case management, do not provide information on the parasite density nor the species differentiation necessary for research and drug efficacy assessment. Microscopy therefore retains key advantages over a number of newer technologies, but its reliability is severely impeded by dependence on high technical competence of the human operators as well as availability of high quality equipment and reagents. Recent studies have demonstrated frequent poor specificity and sensitivity associated with manual microscopy diagnostics in operational conditions. These drawbacks constitute a major limiting factor to effective monitoring and preservation of vital anti-malarial medicines.
Advances in digital microscopy performance and affordability have now opened the door to potentially significant improvements in the performance of malaria microscopy, overcoming serious deficiencies in current drug efficacy assessment, and more broadly in malaria diagnosis and management. Global Good (GG)/Intellectual Ventures Laboratory (IVL) sponsored by the Global Good Fund, has developed a microscope prototype consisting of low cost components to scan and capture images from Giemsa-stained thick blood films on slides. The captured images are analyzed with custom image analysis software developed at GG/IVL, using algorithms that are designed for automatic malaria diagnosis, without user input. Versions of a prototype of the device were first tested in field settings in Thailand in 2014-2015 at clinics operated by the Shoklo Malaria Research Unit (SMRU) and then again in 2016-2017. When compared to expert microscopy at SMRU, the performance of the device with respect to diagnostic sensitivity (87.8%), species identification (85.6% species correctly identified) and parasite density estimation (44% of estimates within +/-25% of reference microscopy result) corresponded to WHO Competence Level 2. The device and the accompanying image analysis algorithms have since been further developed and a new, third version of the prototype is now available for testing in diverse settings with varying malaria prevalence and user expertise.
Read the detailed description
The primary purpose of this evaluation is to quantify the diagnostic performance of the EasyScan Go prototype in various field settings. The performance of the EasyScan Go prototype will be assessed by scanning of negative and positive slides with the EasyScan Go and comparing the results with expert microscopy. Plasmodium genus- and species-specific PCR will also be performed on samples collected at some sites as an additional confirmatory test for the detection of malaria parasites and their species if present. Testing by microscopy and EasyScan Go will be performed in field clinic settings on Giemsa-stained slides prepared from febrile patient blood collected from a finger-prick. Further work will be undertaken at the WWARN laboratory in Bangkok for data analyses and for quality assurance.
Funder: Intellectual Ventures Lab/Global Good (2018) Sponser: University of Oxford Grant refernce number:The Global Good Fund I, LLC PA No.5
- Conditions
- Malaria
- Medical subject headings
- Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic sensitivity for malaria parasite detection
Measured: 6 months
Diagnostic specificity for malaria parasite detection
Measured: 6 months
Kappa statistic for parasite species identification
Measured: 6 months
Bland-Altman plots for parasite density estimation
Measured: 6 months
Secondary outcomes (4)
Reliability (comparison between 2 devices and repeat reads)
Measured: 6 months
Cost-effectiveness as compared with routine methods
Measured: 6 months
Prevalence of parasite genetic markers of resistance to antimalarials by location and time period
Measured: 6 months
Prevalence of parasites carrying deletions of pfhrp2/3 genes by location and time period
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start25 Jun 2018
- Primary completion31 Oct 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512678
- Sponsor's protocol ID
- MAL18002
- Acronym
- EasyScanGo
- Status last verified
- Sep 2020
- First submitted
- 18 Apr 2018
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Das D, Vongpromek R, Assawariyathipat T, Srinamon K, Kennon K, Stepniewska K, Ghose A, Sayeed AA, Faiz MA, Netto RLA, Siqueira A, Yerbanga SR, Ouedraogo JB, Callery JJ, Peto TJ, Tripura R, Koukouikila-Koussounda F, Ntoumi F, Ong'echa JM, Ogutu B, Ghimire P, Marfurt J, Ley B, Seck A, Ndiaye M, Moodley B, Sun LM, Archasuksan L, Proux S, Nsobya SL, Rosenthal PJ, Horning MP, McGuire SK, Mehanian C, Burkot S, Delahunt CB, Bachman C, Price RN, Dondorp AM, Chappuis F, Guerin PJ, Dhorda M. Field evaluation of the diagnostic performance of EasyScan GO: a digital malaria microscopy device based on machine-learning. Malar J. 2022 Apr 12;21(1):122. doi: 10.1186/s12936-022-04146-1.
PubMed 35413904
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centric Evaluation of a Device for Automated Malaria Microscopy (EasyScan Go)
- ClinicalTrials.gov ID
- NCT03512678
- Acronym / sponsor ID
- EasyScanGo / MAL18002
- Conditions
- Malaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,250 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Light microscopy, which is based on century-old technology, remains a key indicator in drug efficacy testing performed in the context of clinical trials for monitoring existing antimalarial drugs or in the context of regulatory clinical trials for registration of new drugs. It is one of the main diagnostic methods for malaria diagnosis in general, as in an ideal setting it can provide low-cost accurate diagnosis, determine the density of parasites in the blood, and accurately differentiate between different malaria parasite species, characteristics vital to the implementation of global plans for drug efficacy monitoring. Malaria rapid tests (RDTs), while useful for rapid diagnosis and case management, do not provide information on the parasite density nor the species differentiation necessary for research and drug efficacy assessment. Microscopy therefore retains key advantages over a number of newer technologies, but its reliability is severely impeded by dependence on high technical competence of the human operators as well as availability of high quality equipment and reagents. Recent studies have demonstrated frequent poor specificity and sensitivity associated with manual microscopy diagnostics in operational conditions. These drawbacks constitute a major limiting factor to effective monitoring and preservation of vital anti-malarial medicines.
Advances in digital microscopy performance and affordability have now opened the door to potentially significant improvements in the performance of malaria microscopy, overcoming serious deficiencies in current drug efficacy assessment, and more broadly in malaria diagnosis and management. Global Good (GG)/Intellectual Ventures Laboratory (IVL) sponsored by the Global Good Fund, has developed a microscope prototype consisting of low cost components to scan and capture images from Giemsa-stained thick blood films on slides. The captured images are analyzed with custom image analysis software developed at GG/IVL, using algorithms that are designed for automatic malaria diagnosis, without user input. Versions of a prototype of the device were first tested in field settings in Thailand in 2014-2015 at clinics operated by the Shoklo Malaria Research Unit (SMRU) and then again in 2016-2017. When compared to expert microscopy at SMRU, the performance of the device with respect to diagnostic sensitivity (87.8%), species identification (85.6% species correctly identified) and parasite density estimation (44% of estimates within +/-25% of reference microscopy result) corresponded to WHO Competence Level 2. The device and the accompanying image analysis algorithms have since been further developed and a new, third version of the prototype is now available for testing in diverse settings with varying malaria prevalence and user expertise.
Detailed description
The primary purpose of this evaluation is to quantify the diagnostic performance of the EasyScan Go prototype in various field settings. The performance of the EasyScan Go prototype will be assessed by scanning of negative and positive slides with the EasyScan Go and comparing the results with expert microscopy. Plasmodium genus- and species-specific PCR will also be performed on samples collected at some sites as an additional confirmatory test for the detection of malaria parasites and their species if present. Testing by microscopy and EasyScan Go will be performed in field clinic settings on Giemsa-stained slides prepared from febrile patient blood collected from a finger-prick. Further work will be undertaken at the WWARN laboratory in Bangkok for data analyses and for quality assurance.
Funder: Intellectual Ventures Lab/Global Good (2018) Sponser: University of Oxford Grant refernce number:The Global Good Fund I, LLC PA No.5
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 75 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The multi-centric evaluation is currently planned for implementation at relatively few sites/countries and the primary criteria for the selection of sites will be based on operational feasibility of the project, i.e., availability of resources to perform the study procedures, adequate expected numbers of malaria positive cases, etc. Potential sites in Senegal, Kenya, Tanzania, Uganda, Congo, South Africa, Burkina Faso, Brazil, Thailand, Indonesia, Bangladesh, Myanmar and Cambodia are being considered for the study. A minimum of 80 malaria cases confirmed by expert microscopy and a minimum of 80 malaria-negative cases per study site.
Key inclusion criteria (3 listed)
- Male or female subjects, age ≥ 6 months to 75 years
- Febrile at presentation or history of fever in the past 48 hours (≥ 37.5 ºC) and no other obvious diagnosis or cause for fever, warranting malaria investigation under routine clinical practice.
- Individual informed assent/consent obtained
Key exclusion criteria (1 listed)
- Signs of severe malaria as defined by WHO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic sensitivity for malaria parasite detection
Time frame: 6 months
Diagnostic specificity for malaria parasite detection
Time frame: 6 months
Kappa statistic for parasite species identification
Time frame: 6 months
Bland-Altman plots for parasite density estimation
Time frame: 6 months
4 secondary outcomes
Reliability (comparison between 2 devices and repeat reads)
Time frame: 6 months
Cost-effectiveness as compared with routine methods
Time frame: 6 months
Prevalence of parasite genetic markers of resistance to antimalarials by location and time period
Time frame: 6 months
Prevalence of parasites carrying deletions of pfhrp2/3 genes by location and time period
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Derived from this study: PubMed 35413904Das D, Vongpromek R, Assawariyathipat T, Srinamon K, Kennon K, Stepniewska K, Ghose A, Sayeed AA, Faiz MA, Netto RLA, Siqueira A, Yerbanga SR, Ouedraogo JB, Callery JJ, Peto TJ, Tripura R, Koukouikila-Koussounda F, Ntoumi F, Ong'echa JM, Ogutu B, Ghimire P, Marfurt J, Ley B, Seck A, Ndiaye M, Moodley B, Sun LM, Archasuksan L, Proux S, Nsobya SL, Rosenthal PJ, Horning MP, McGuire SK, Mehanian C, Burkot S, Delahunt CB, Bachman C, Price RN, Dondorp AM, Chappuis F, Guerin PJ, Dhorda M. Field evaluation of the diagnostic performance of EasyScan GO: a digital malaria microscopy device based on machine-learning. Malar J. 2022 Apr 12;21(1):122. doi: 10.1186/s12936-022-04146-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by University of Oxford at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic sensitivity for malaria parasite detection (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03512678, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.